BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X AORTIC PROSTHETIC HEART VALVE

    MDR report key: 2123111 · Received December 8, 2008

    Report

    Report Number
    1649833-2008-00009
    Event Type
    Injury
    Date Received
    December 8, 2008
    Date of Event
    September 15, 2008
    Report Date
    December 3, 2008
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE WAS CLEAN OF THROMBUS WHEN REC'D AND MET ALL MFG SPECIFICATIONS.

    Description of Event or Problem · 1

    PT WITH HISTORY OF IV DRUG ABUSE, HEPATITIS AND HYPERCOAGUABILITY WAS REOPERATED AFTER EXAMINATIONS SHOWED A LEAFLET NOT CLOSING FULLY. AT REOPERATION, A SMALL THROMBUS WAS FOUND IN A HINGE THAT WAS EASILY REMOVED. THE VALVE WAS REPLACED WITH ANOTHER MAKE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-X AORTIC PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention